Tolero Pharmaceuticals

Tolero Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical firm focused on discovering and developing therapeutics for hematologic and oncologic diseases. Founded in 2011 by Dallin Anderson and David J. Bearss, the company is headquartered in Lehi, Utah. Dr. Bearss, a seasoned entrepreneur and drug developer with over two decades of experience in both academic and industry settings, has co-founded eight biotech companies and has discovered 16 compounds that have advanced to clinical development. His work concentrates on small-molecule drug development and utilizing genetic models for drug discovery.

The company's business model revolves around its internal research and development capabilities to build a pipeline of drug candidates. A key milestone for Tolero was the acquisition by the Japanese firm Sumitomo Dainippon Pharma in a deal announced in December 2016 and completed in January 2017. The acquisition, valued at up to $780 million, included a $200 million upfront payment with further milestone payments tied to development and commercial success. Following the acquisition, Tolero became a wholly-owned subsidiary of Sumitomo Dainippon Pharma America Holdings, Inc., and in July 2020, it was merged with Boston Biomedical to form Sumitomo Dainippon Pharma Oncology.

Tolero's lead product candidate is Alvocidib, a small molecule inhibitor of cyclin-dependent kinase 9 (CDK9). Alvocidib, which was licensed from Sanofi, targets the protein P-TEFb, which is involved in the transcription of cancer-related genes. By inhibiting CDK9, Alvocidib aims to suppress the production of MCL-1, a protein that helps cancer cells survive by preventing programmed cell death (apoptosis). This mechanism is being investigated for the treatment of hematologic malignancies such as Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). Alvocidib has received Orphan Drug Designation in both the United States and Europe for the treatment of AML. The company is also developing TP-1287, an oral prodrug of Alvocidib, among other compounds in its pipeline targeting various oncologic pathways.

Keywords: oncology therapeutics, hematologic diseases, drug discovery, clinical-stage biopharmaceutical, CDK9 inhibitor, Alvocidib, Acute Myeloid Leukemia, cancer research, small molecule drugs, Sumitomo Dainippon Pharma Oncology, David J. Bearss, Dallin Anderson, apoptosis, MCL-1 inhibitor, Myelodysplastic Syndromes, kinase inhibitors, biopharmaceutical, cancer treatment, drug development, TP-1287, biomarker detection, oncogenic pathways, hematologic malignancies, clinical trials, orphan drug